510(k) K121412
K121412 is an FDA 510(k) premarket notification submitted by VATECH Co., Ltd. for the device "PAX-FLEX3D, PHT-7000". The FDA issued a decision of Substantially Equivalent on Jun 8, 2012. The device falls under product code OAS (X-Ray, Tomography, Computed, Dental), a Class II device regulated under 21 CFR 892.1750. VATECH Co., Ltd. has 39 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 8, 2012
- Date Received
- May 11, 2012
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- X-Ray, Tomography, Computed, Dental
- Device Class
- Class II
- Regulation Number
- 892.1750
- Review Panel
- RA
- Submission Type
- 510(k)
Produce cross-sectional diagnostic x-ray images of the intra-oral tissue and teeth.